No More Placebos: Sweet Solutions Control Pain in Infants

Beth Skwarecki

December 16, 2016

Sweet solutions clearly help mitigate pain in newborns, and further placebo-controlled trials are not needed or ethical, the authors of a new meta-analysis conclude.

"Future neonatal pain studies need to select more ethically responsible control groups," Denise Harrison, PhD, of the Children's Hospital of Ontario Research Institute and the School of Nursing at the University of Ottawa, Canada, and colleagues write in an article published online December 16 in Pediatrics.

Two previous meta-analyses — one on sucrose-based solutions and one on their nonsucrose counterparts, including glucose — had come to the same conclusion, but their methodology only allowed a small number of trials to be included. Those authors had excluded dozens of trials because of the wide variation in procedures, outcomes, types of solution used, and other factors.

Therefore, Dr Harrison and colleagues chose a design that included all the trials the previous reviews had considered, as long as they reported behavioral outcomes of crying duration or composite pain scores. In total, the authors included 168 studies published since 1991 that tested sweet solutions as a neonatal analgesic. They were able to pool data for 62 of the trials for the new analysis.

Overall, 50 trials of 3341 infants found a standardized mean difference in pain scores of −0.90 in favor of the sweet solutions over control or placebo (95% confidence interval, −1.09 to −0.70). For crying time, the mean difference was −23.18 seconds in favor of sweet solutions (95% confidence interval, −28.89 to −17.47) in 29 trials totaling 1775 infants.

"[S]ince the first few trials were published, there was sufficient evidence to show that sweet solutions reduce behavioral responses of crying time and composite pain intensity scores compared with no treatment or placebo," the authors write.

In 2001, the International Evidence Based Group for Neonatal Pain published guidelines recommending the use of sucrose solutions for painful procedures. However, studies with a no-treatment control have continued to be conducted since then, with no change in conclusions. A Cochrane review updated in February 2016 found high-quality evidence for a 24% solution of sucrose to reduce pain during venipuncture, heel lance, and intramuscular injections.

"Although we still have much to learn from research on pain in infants, we must remain cognizant of using current evidence to reduce pain while we continue to advance the science of pain management in sick and healthy preterm and term infants," Dr Harrison and colleagues write.

"[I]t is our position that it is unethical to continue to conduct placebo or no-treatment controlled trials in infants," the authors conclude.

The authors have disclosed no relevant financial relationships.

Pediatrics. Published online December 16, 2016. Abstract

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